Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the efficacy and safety of Tanzânia association in adults with erectile dysfunction associated with Benign Prostatic Hyperplasia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Tamsulosin

Criteria

Inclusion Criteria:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;

• Male participants aged 18 years or more;

• Sexually active participants with a defined partner who have averaged 1 attempt at sexual intercourse per week in the past month;

• Diagnosis of Benign Prostatic Hyperplasia;

• Diagnosis of erectile dysfunction;

• Patients with score between 6 and 25 points in the erectile function questionnaire;

• IPSS (International Prostate Symptom Score) greater or equal to 8 points;

Exclusion Criteria:

• Known hypersensitivity to the formula components used during the clinical trial;

• History of alcohol and/or substance abuse within 2 years;

• Diagnosis of other diseases or conditions in the urinary tract, including but not limited to: cancer, neurogenic bladder; urinary incontinence, recurrent infection, urethral stricture, bacterial prostatitis;

• Clinical evidence of prostate cancer;

• Hypogonadism or absent sexual desire;

• Severe psychiatric or psychosocial disorders;

• Primary erectile dysfunction;

• Polyneuropathy, neurodegenerative diseases, trauma or spinal cord injuries, central nervous system tumors or other conditions that may affect erections;

• Anatomical penile deformation that can significantly impair erection, including but not limited to: angulation, cavernous fibrosis, Peyronie's disease.